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ONC-392 plus Lu 177 vipivotide in ARTA resistant mCRPC

The main purpose of the study is to determine whether the study drug, ONC-392, together with a standard of care drug PLUVICTO® (Lutetium Lu 177 Vipivotide Tetraxetan), are safe and well tolerated, and whether two drugs are effective in treating prostate cancer, in comparison with the standard of care PLUVICTO® alone.

Age & Gender

18 years ~ 99 years
Male

Visit Availability

Standard business hours (M-F, 8-5)

Location

North Carolina (Statewide)

What will be asked of you

The study involves physical exams, vital signs, blood draws for labs and research, PET/CT scans, tumor biopsies, questionnaires, adverse event assessments, and study drug treatment.

Incentives

ONC-392, will be supplied at no charge while you taking part in this study.

Total length of participation:
at least 2 years

Looking for Specific Volunteers

Able to participate:

Patients must have an ECOG performance status of 0 or 1.
Patients must have a life expectancy of greater than six months.
Patients must have confirmed progressive metastatic castration-resistant prostate cancer.
Patients must have one or more metastatic lesions present on baseline imaging.
Patients must have adequate organ function per lab values in protocol.

Not eligible if:

Patient received any other anti-cancer agent therapy within 28 days.
Patient had a transfusion with 14 days.
Patient has any concurrent serious medical conditions per protocol that in the opinion of the investigator would impair study participation.
Patient is diagnosed with other malignancies that could alter life expectancy or interfere with disease assessment.
Patient has active GI disease or autoimmune disease.

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Clinical Trials Office
cancerclinicaltrials@med.unc.edu

Primary Visit Location

NC Women's Hospital
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Young Whang
Lineberger Comprehensive Cancer Center

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Prostate)
Men's Health

IRB Number

23-3228

ClinicalTrials.gov

NCT05682443

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Questions?

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